Trial Outcomes & Findings for Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery (NCT NCT03806270)

Last Updated: 2019-10-22

Results Overview

The lowest heart rate observed from EKG monitorization at the "time-out" after the anesthesia induction, and just before the surgery starts. Heart rate-1 is a data, not an assessing change, which is recoded during the "time-out". "The time-out" is when the patient's name, the procedure, the surgent name is repeated before the operation starts.

Recruitment status

COMPLETED

Target enrollment

45 participants

Primary outcome timeframe

1 minute, at the "time out", through study completion an average of 6 months

Results posted on

2019-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Midazolam Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice	Midazolam&Hydroxyzine dihydrochloride1/2 Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Midazolam&Hydroxyzine Dihydrochloride Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally
Overall Study STARTED	15	15	15
Overall Study COMPLETED	15	15	15
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 minute, at the "time out", through study completion an average of 6 months

Population: Heart Rate1 was measured from each of the 45 participants, during "time-out" right after anesthesia induction and before surgery begins. This measurement is not related to orbital muscle traction.

Outcome measures

Outcome measures
Measure	Midazolam n=15 Participants Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice	Midazolam&Hydroxyzine dihydrochloride1/2 n=15 Participants Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Midazolam&Hydroxyzine Dihydrochloride n=15 Participants Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally
Heart Rate-1	114.4 beats per minute Standard Deviation 22.1	125.8 beats per minute Standard Deviation 13.5	122.3 beats per minute Standard Deviation 13.7

PRIMARY outcome

Timeframe: 1 minute, at the strabismus surgery operation, through study completion an average of 6 months

Population: "Orbital muscles" which surgery performed. It is not equal to the participant number. Related to strabismus surgery, the number of muscles surgery performed on a participant might change; like as one eye 2 muscles, two eyes but 1 muscle for each eye or two eyes 2 muscle for each.

The heart rate observed from EKG monitorization at the time operator warns the investigator just before the traction of the orbital muscle. Heart rate-2 is a data, not an assessing change, which is recorded during the operation at the time operator warns. The heart rate observed from EKG monitorization, before every orbital muscle traction at the time the operator's warning before traction.

Outcome measures

Outcome measures
Measure	Midazolam n=29 Orbital Muscles Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice	Midazolam&Hydroxyzine dihydrochloride1/2 n=28 Orbital Muscles Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Midazolam&Hydroxyzine Dihydrochloride n=30 Orbital Muscles Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally
Heart Rate-2	110.4 beats per minute Standard Deviation 14.1	125.3 beats per minute Standard Deviation 13.1	124.8 beats per minute Standard Deviation 11.9

PRIMARY outcome

Timeframe: within 120 seconds after the orbital muscle traction, at the strabismus surgery operation, through study completion an average of 6 months

The lowest heart rate observed from EKG monitorization, after every orbital muscle traction within 120 seconds. Heart rate-3 is a data, not an assessing change, which is recorded within 120 seconds after traction applied.

Outcome measures

Outcome measures
Measure	Midazolam n=29 Orbital Muscles Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice	Midazolam&Hydroxyzine dihydrochloride1/2 n=28 Orbital Muscles Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Midazolam&Hydroxyzine Dihydrochloride n=30 Orbital Muscles Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally
Heart Rate-3	90.8 beats per minute Standard Deviation 16.6	113.4 beats per minute Standard Deviation 15.6	117.9 beats per minute Standard Deviation 12.7

PRIMARY outcome

Timeframe: 2 minutes, at the strabismus surgery operation after recording Heart Rate-3, through study completion an average of 6 months

Population: OCR occurrence (0: no and 1: yes) was recorded for every orbital muscle. So it is not equal to the participant number.

The OCR is a heartbeat anomaly(bradycardia, any arrhythmia, or cardiac arrest) associated with traction applied to the extraocular muscles during strabismus surgery. The specific criteria were as follows: the lowest heart rate observed within 120 seconds from EKG monitorization, after every orbital muscle traction, was less than 20% of the heart rate observed directly preceding traction of the orbital muscle. Additionally, any kind of arrhythmia or cardiac arrest occurrence within 120 seconds after orbital muscle traction was also defined as an OCR.

Outcome measures

Outcome measures
Measure	Midazolam n=29 orbital muscles Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice	Midazolam&Hydroxyzine dihydrochloride1/2 n=28 orbital muscles Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Midazolam&Hydroxyzine Dihydrochloride n=30 orbital muscles Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally
Number of Observed Oculocardiac Reflex(OCR)	15 orbital muscles	6 orbital muscles	1 orbital muscles

SECONDARY outcome

Timeframe: After patient transferred into the operation theatre and before anesthesia induction, through study completion an average of 6 months

Population: every participant that had only midazolam or one of the midazolam and hydroxizine premedications before surgery. Ramsay sedation score is evaluated by the investigator before surgery, in the operating theatre without knowing which premedication was utilized to the participant.

If Awake; Ramsay 1: Anxious, agitated, restless; Ramsay 2: Cooperative, oriented, tranquil; Ramsay 3: Responsive to commands only If Asleep; Ramsay 4: Brisk response to a light glabellar tap or loud auditory stimulus; Ramsay 5: Sluggish response to a light glabellar tap or loud auditory stimulus; Ramsay 6: No response to a light glabellar tap or loud auditory stimulus

Outcome measures

Outcome measures
Measure	Midazolam n=15 Participants Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice	Midazolam&Hydroxyzine dihydrochloride1/2 n=15 Participants Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Midazolam&Hydroxyzine Dihydrochloride n=15 Participants Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally
Ramsay Sedation Score Ramsay 1	2 Participants	0 Participants	2 Participants
Ramsay Sedation Score Ramsay 2	13 Participants	15 Participants	9 Participants
Ramsay Sedation Score Ramsay 3	0 Participants	0 Participants	4 Participants
Ramsay Sedation Score Ramsay 4	0 Participants	0 Participants	0 Participants
Ramsay Sedation Score Ramsay 5	0 Participants	0 Participants	0 Participants
Ramsay Sedation Score Ramsay 6	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: within 5 minutes after defining the OCR occurrence, at the strabismus surgery operation, through study completion an average of 6 months

Population: midazolam group includes 15 participants; total 29 orbital muscles operated, in 15 of them OCR occurred. Midazolam\&Hydroxyzine1/2 group includes 15 participants; total 28 orbital muscles operated, in 6 of them OCR occurred. Midazolam\&Hydroxyzine group includes 15 participants; total 30 orbital muscles operated, in 1 of them OCR occurred.

The investigator records every OCR treatment like; pausing surgery, atropin 20mcg/kg intravenous treatment or cardiac resuscitation.

Outcome measures

Outcome measures
Measure	Midazolam n=15 number of orbital muscle/s, OCR occured Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice	Midazolam&Hydroxyzine dihydrochloride1/2 n=6 number of orbital muscle/s, OCR occured Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Midazolam&Hydroxyzine Dihydrochloride n=1 number of orbital muscle/s, OCR occured Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally
Number of Orbital Muscles of the Participants With Different Considerations Taken With Respect to the Treatment of OCR pausing surgery	13 number of orbital muscle/s, OCR occured	6 number of orbital muscle/s, OCR occured	1 number of orbital muscle/s, OCR occured
Number of Orbital Muscles of the Participants With Different Considerations Taken With Respect to the Treatment of OCR atropin administration	2 number of orbital muscle/s, OCR occured	0 number of orbital muscle/s, OCR occured	0 number of orbital muscle/s, OCR occured
Number of Orbital Muscles of the Participants With Different Considerations Taken With Respect to the Treatment of OCR cardiac resuscitation	0 number of orbital muscle/s, OCR occured	0 number of orbital muscle/s, OCR occured	0 number of orbital muscle/s, OCR occured

OTHER_PRE_SPECIFIED outcome

Timeframe: within 5 minutes after defining the OCR occurrence, at the strabismus surgery operation, through study completion an average of 6 months

Population: The names of the orbital muscles which OCR occurred after traction was performed

The investigator records the orbital muscle name which OCR occurred during its traction; like Right eye medial rectus muscle, Right eye inferior oblique muscle, Right eye lateral rectus muscle, Left eye medial rectus muscle, Left eye inferior oblique muscle, Left eye lateral rectus muscle.

Outcome measures

Outcome measures
Measure	Midazolam n=15 Orbital muscles which OCR occurred Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice	Midazolam&Hydroxyzine dihydrochloride1/2 n=6 Orbital muscles which OCR occurred Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Midazolam&Hydroxyzine Dihydrochloride n=1 Orbital muscles which OCR occurred Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally
The Orbital Muscle Name Which OCR Occurred During it's Traction Right eye medial rectus	5 Orbital muscles which OCR occurred	3 Orbital muscles which OCR occurred	1 Orbital muscles which OCR occurred
The Orbital Muscle Name Which OCR Occurred During it's Traction Right eye lateral rectus	3 Orbital muscles which OCR occurred	0 Orbital muscles which OCR occurred	0 Orbital muscles which OCR occurred
The Orbital Muscle Name Which OCR Occurred During it's Traction Left eye medial rectus	6 Orbital muscles which OCR occurred	2 Orbital muscles which OCR occurred	0 Orbital muscles which OCR occurred
The Orbital Muscle Name Which OCR Occurred During it's Traction Left eye lateral rectus	1 Orbital muscles which OCR occurred	1 Orbital muscles which OCR occurred	0 Orbital muscles which OCR occurred

Adverse Events

Midazolam&Hydroxyzine Dihydrochloride

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam&Hydroxyzine dihydrochloride1/2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ferda F. Kartufan

Yeditepe U

Phone: +902165784000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Midazolam n=15 Participants Demizolam, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with cherry juice of maximum 5 ml. in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication and doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice	Midazolam&Hydroxyzine dihydrochloride1/2 n=15 Participants Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with hydroxyzine dihydrochloride (dose of 0.5 mg/kg) in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Midazolam&Hydroxyzine Dihydrochloride n=15 Participants Midazolam and Hydroxyzine dihydrochloride, once on the operation day, usually ordered 15 minutes before strabismus operation by another anesthesiologist who is charged to perform anesthesia who is not related with the trial.The maximum dose of 0.5 mg/kg midazolam is given orally with the maximum dose of 1mg/kg hydroxyzine dihydrochloride in Yeditepe University Hospital to the pediatric patients by the anesthesiologists. In all groups patients are not selected to the groups and premedication doses are not given by the investigator, they grouped according to the premedication given by the anesthesiologists, after the operation retrospectively. Midazolam: Demizolam 15mg/ml ampules, given orally with cherry juice Hydroxyzine Dihydrochloride: Atarax 2mg/ml syrup, given orally	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	6.3 years STANDARD_DEVIATION 2.5 • n=5 Participants	3.5 years STANDARD_DEVIATION 2.2 • n=7 Participants	2.9 years STANDARD_DEVIATION 1.8 • n=5 Participants	4.2 years STANDARD_DEVIATION 2.6 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants
Region of Enrollment Turkey	15 participants n=5 Participants	15 participants n=7 Participants	15 participants n=5 Participants	45 participants n=4 Participants
Heart Rate 1	114.4 beats per minute STANDARD_DEVIATION 22.1 • n=5 Participants	125.8 beats per minute STANDARD_DEVIATION 13.5 • n=7 Participants	122.33 beats per minute STANDARD_DEVIATION 13.7 • n=5 Participants	120.8 beats per minute STANDARD_DEVIATION 17.2 • n=4 Participants